EP3074313B1 - Vorrichtung und verfahren zur aseptischen füllung - Google Patents

Vorrichtung und verfahren zur aseptischen füllung Download PDF

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Publication number
EP3074313B1
EP3074313B1 EP15720105.4A EP15720105A EP3074313B1 EP 3074313 B1 EP3074313 B1 EP 3074313B1 EP 15720105 A EP15720105 A EP 15720105A EP 3074313 B1 EP3074313 B1 EP 3074313B1
Authority
EP
European Patent Office
Prior art keywords
tube
sterile
packaging
container
hopper
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP15720105.4A
Other languages
English (en)
French (fr)
Other versions
EP3074313A1 (de
Inventor
Bertrand CORMARY
Laurent SERRA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pierre Fabre Dermo Cosmetique SA
Original Assignee
Pierre Fabre Dermo Cosmetique SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pierre Fabre Dermo Cosmetique SA filed Critical Pierre Fabre Dermo Cosmetique SA
Publication of EP3074313A1 publication Critical patent/EP3074313A1/de
Application granted granted Critical
Publication of EP3074313B1 publication Critical patent/EP3074313B1/de
Active legal-status Critical Current
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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/04—Methods of, or means for, filling the material into the containers or receptacles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04—Heat
    • A61L2/06—Hot gas
    • A61L2/07—Steam
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/04—Methods of, or means for, filling the material into the containers or receptacles
    • B65B3/16—Methods of, or means for, filling the material into the containers or receptacles for filling collapsible tubes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B31/00—Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
    • B65B31/02—Filling, closing, or filling and closing, containers or wrappers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B51/00—Devices for, or methods of, sealing or securing package folds or closures; Devices for gathering or twisting wrappers, or necks of bags
    • B65B51/10—Applying or generating heat or pressure or combinations thereof
    • B65B51/22—Applying or generating heat or pressure or combinations thereof by friction or ultrasonic or high-frequency electrical means, i.e. by friction or ultrasonic or induction welding
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/027—Packaging in aseptic chambers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/12—Sterilising contents prior to, or during, packaging
    • B65B55/18—Sterilising contents prior to, or during, packaging by liquids or gases
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00—Closing containers or receptacles after filling
    • B65B7/14—Closing collapsible or resilient tubes, e.g. for tooth paste, for lighter fuel
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B39/00—Nozzles, funnels or guides for introducing articles or materials into containers or wrappers

Claims (13)

  1. Konditioniervorrichtung für ein steriles loses Gut, insbesondere für eine hautkosmetische oder galenische Präparation in einem Behältnis (110),
    umfassend:
    a. eine sterile Kammer (101) und in dieser sterilen Kammer
    b. einen das lose Gut enthaltenden Trichter (200), der in einer axialen Richtung einen zylinderförmigen Behälterteil (201) und einen am zylinderförmigen Teil (201) angeschlossenen Auslaufabschnitt (202) umfasst;
    c. eine Übertragungsvorrichtung (115), die das Behältnis (110) unter den Trichter (200) in Hinblick auf sein Einfüllen in einem sogenannten Einfüllbereich transportieren kann;
    d. eine von der Decke bis zum Boden der Kammer (101) agierende Blaseinrichtung (150) für ultrafiltrierte Luft, die einen sogenannten Schutzluftstrom um den Einfüllbereich herum erzeugen kann,
    dadurch gekennzeichnet, dass die Achse (205) des unsymmetrischen kegelförmigen Auslaufabschnitts (202) in Bezug zur Achse (210) des Kammerteils (201) derart außermittig ist, dass die Auslauföffnung (206) in Richtung der Außenwand des Behälters verschoben ist.
  2. Vorrichtung nach Anspruch 1, umfassend:
    f. Ansaugmittel (250), die einen über die Übertragungsvorrichtung (115) strömenden Luftstrom erzeugen.
  3. Vorrichtung nach Anspruch 1, bei der das Behältnis (110) eine biegsame, an einem Ende geschlossene Tube ist, wobei die Vorrichtung umfasst:
    g. Mittel (415), um die biegsame Tube auf der Übertragungsvorrichtung zu halten und das offene Ende der Tube (110) unter der Auslauföffnung zu präsentieren;
    h. eine Abdichtstation (140) für das offene Tubenende, die von der Übertragungsvorrichtung nach dem Einfüllbereich gesteuert wird, wobei die Abdichtstation unter dem Schutzstrom liegt.
  4. Vorrichtung nach Anspruch 3, bei der die Tube (110) aus einem thermoplastischen Material besteht und das Abdichten durch Stumpfschweißen (440) des offenen Tubenendes realisiert wird.
  5. Vorrichtung nach Anspruch 3, bei der das ursprünglich geschlossene Ende der biegsamen Tube ein Verschluss (211) ist, der die Rückkontaminierung des in der Tube enthaltenen Produkts verhindern kann.
  6. Vorrichtung nach Anspruch 3, bei der die Mittel zum Halten der biegsamen Tube auf der Übertragungsvorrichtung einen wabenförmigen Behälter (415) umfassen, in den die biegsamen Tuben (110) gesteckt werden.
  7. Verfahren für die Herstellung und Konditionierung eines sterilen losen Guts, insbesondere einer hautkosmetischen oder galenischen Präparation, bei dem eine Konditioniervorrichtung nach Anspruch 1 und eine Aufgusssterilisationsvorrichtung (320) mit einem Dampfgenerator zum Einsatz kommen,
    dadurch gekennzeichnet, dass es folgende Arbeitsschritte umfasst:
    i. Sterilisieren (510) des losen Guts in der Aufgusssterilisationsvorrichtung (320), bei dem ein Verfahren durch Dampfaufguss zum Einsatz kommt;
    ii. Übertragen (515) des so sterilisierten losen Guts in den Trichter einer Konditioniervorrichtung nach Anspruch 1;
    iii. Auffüllen (520) einer sterilen Einheit mit in einen wabenförmigen Behälter montierten Behältnissen;
    iv. Konditionieren (530) des losen Guts in die Behältnisse nach einem Auffüllverfahren, das das Vorbeifahren der Behältnisse in ihrem wabenförmigen Behälter unter dem Trichter der Konditioniervorrichtung unter einem ultrafiltrierten Laminar-Flow umfasst.
  8. Verfahren nach Anspruch 7, bei dem der Arbeitsschritt ii) durch direkte Übertragung von der Dampfaufgussvorrichtung zum Trichter realisiert wird.
  9. Verfahren nach Anspruch 7, das zwischen dem Arbeitsschritt i) und dem Arbeitsschritt ii) folgenden Arbeitsschritt umfasst:
    v. Lagern des sterilisierten losen Guts in einem geschlossenen sterilen Kessel, wobei der Arbeitsschritt ii) durch Übertragen des losen Guts vom Kessel in den Trichter bewerkstelligt wird.
  10. Verfahren nach Anspruch 7, das vor dem Arbeitsschritt i) folgenden Arbeitsschritt umfasst:
    vi. Sterilisieren der kompletten Installation, die die Konditioniervorrichtung nach Anspruch 1 und die Aufgusssterilisationsvorrichtung (320) umfasst, durch Zirkulation in der Dampfanlage bei hoher Temperatur, die von der Aufgusssterilisationsvorrichtung erzeugt wird.
  11. Verfahren nach Anspruch 7, bei dem das Behältnis eine Tube mit einem Füllvermögen zwischen 50 ml und 400 ml und einen eine Retrokontamination verhindernden Verschluss umfasst.
  12. Verfahren nach Anspruch 11, das folgenden Arbeitsschritt umfasst: viii. Schließen der Tube nach dem Auffüllen durch eine Schweißnaht.
  13. Verfahren nach Anspruch 12, bei dem das lose Gut umfasst:
    - 2 % bis 5 % Cetearylglucosid;
    - 0,1 % bis 0,5 % Carbomer;
    - 5 % bis 12 % Glycerin;
    - 2 % bis 10 % Capryl-Caprin-Triglycerid;
    - 5 % bis 10 % flüssiges Paraffin;
    - Wasser zum Ergänzen auf 100%
    und keinerlei Konservierungsmittel.
EP15720105.4A 2014-05-09 2015-05-11 Vorrichtung und verfahren zur aseptischen füllung Active EP3074313B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1454174A FR3020800B1 (fr) 2014-05-09 2014-05-09 Dispositif et procede de remplissage aseptique
PCT/EP2015/060394 WO2015169972A1 (fr) 2014-05-09 2015-05-11 Dispositif et procédé de remplissage aseptique

Publications (2)

Publication Number Publication Date
EP3074313A1 EP3074313A1 (de) 2016-10-05
EP3074313B1 true EP3074313B1 (de) 2017-04-26

Family

ID=51610203

Family Applications (1)

Application Number Title Priority Date Filing Date
EP15720105.4A Active EP3074313B1 (de) 2014-05-09 2015-05-11 Vorrichtung und verfahren zur aseptischen füllung

Country Status (9)

Country Link
US (1) US20170240310A1 (de)
EP (1) EP3074313B1 (de)
JP (1) JP6665114B2 (de)
CN (1) CN107074378B (de)
BR (1) BR112016026149B1 (de)
CA (1) CA2948427C (de)
ES (1) ES2633498T3 (de)
FR (1) FR3020800B1 (de)
WO (1) WO2015169972A1 (de)

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CN108238291B (zh) * 2018-04-24 2018-11-27 嵊州市诺米克进出口有限公司 一种肿瘤辅助治疗药物装瓶装置
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FR3117459B1 (fr) 2020-12-14 2022-12-16 Cenexi Laborathoires Thissen Procede d’assemblage et de remplissage de conteneurs pour dispositif d’injection sans aiguille
US20240025578A1 (en) 2020-12-14 2024-01-25 Cenexi-Laborathoires Thissen Method for assembling and filling containers for a needleless injection device
BE1028884B1 (fr) 2020-12-14 2022-07-12 Cenexi Laborathoires Thissen Procede d'assemblage et de remplissage de conteneurs pour dispositif d'injection sans aiguille

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Also Published As

Publication number Publication date
ES2633498T3 (es) 2017-09-21
JP6665114B2 (ja) 2020-03-13
CN107074378A (zh) 2017-08-18
FR3020800A1 (fr) 2015-11-13
US20170240310A1 (en) 2017-08-24
CA2948427A1 (fr) 2015-11-12
WO2015169972A1 (fr) 2015-11-12
CA2948427C (fr) 2022-07-12
FR3020800B1 (fr) 2017-08-25
BR112016026149B1 (pt) 2021-05-04
JP2017520481A (ja) 2017-07-27
EP3074313A1 (de) 2016-10-05
CN107074378B (zh) 2019-11-05

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